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Reduction in MMDs from baseline was the primary endpoint in PROMISE-1 and PROMISE-2:2,3 Patients with chronic migraine VYEPTI 100 mg (n=356) -7.7 MMDs, placebo (n=366) -5.6 MMDs,
p<0.0001; mean baseline 16.1 MMDs2 Patients with episodic migraine VYEPTI 100 mg (n=221) -3.9 MMDs, placebo (n=222) -3.2 MMDs,
p=0.0182; mean baseline ~8.6 MMDs3

EFFICACIOUS

VYEPTI reduces the frequency of monthly migraine days (MMD) versus placebo throughout the 12-week dosing period (PROMISE-1 and PROMISE-2 primary endpoint)2,3*

FAST ONSET

VYEPTI starts working from day 1 after infusion2,3,5

Percentage of patients reporting migraine on day 1 after infusion was a secondary endpoint measure:

Patients with chronic migraine (VYEPTI 100 mg, 28.6% versus placebo, 42.3%, p<0.0001)2

Patients with episodic migraine (VYEPTI 100 mg, 14.8% versus placebo, 22.5%, p=0.0312, not statistically significant per the testing hierarchy; unadjusted p-value presented)3

SUSTAINED

VYEPTI only requires a single dose every 12 weeks1

IV INFUSION

VYEPTI is delivered via a 30-minute IV infusion, following dilution in a 100 mL bag of 0.9% Sodium Chloride for Injection, every 12 weeks. The treating healthcare professional should observe or monitor patients during and after the infusion in accordance with normal clinical practice1

SAFETY PROFILE

VYEPTI is generally well tolerated1,6

*Based on primary endpoint data from parallel-group, double-blind, randomised, placebo-controlled efficacy and safety studies in patients with episodic migraine (N=835; PROMISE-1; NCT02559895, -3.9 (VYEPTI) versus -3.2 (placebo) MMDs, mean baseline ~8.6 MMDs, p=0.0182) or chronic migraine (N=1,049; PROMISE-2; NCT02974153, -7.7 (VYEPTI) versus -5.6 (placebo) MMDs, mean (SD) baseline 16.1 (4.6) MMDs, p<0.0001).2,3

VYEPTI significantly reduces frequency of monthly migraine days vs placebo in patients with chronic migraine2

(PROMISE-2 primary endpoint)

VYEPTI significantly reduces frequency of monthly migraine days vs placebo in patients with episodic migraine3

(PROMISE-1 primary endpoint)

VYEPTI significantly reduces monthly migraine days vs placebo in episodic and chronic migraine patients with previous treatment failures7

(DELIVER primary endpoint)
Mean change from baseline in MMDs in adult patients with chronic migraine2
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STUDY DESIGN
Mean change from baseline in MMDs in adult patients with episodic migraine3
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STUDY DESIGN
Mean change from baseline in MMDs in patients with episodic or chronic migraine with 2–4 previous preventive treatment failures7
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STUDY DESIGN

More chronic migraine patients reduce their monthly migraine days by ≥50% when treated with VYEPTI vs placebo2

(PROMISE-2 secondary endpoint)

More episodic and chronic migraine patients with previous preventive treatment failures reduce their migraine days by ≥50% when treated with VYEPTI vs placebo7

(DELIVER secondary endpoint)
Proportion of patients with ≥50% MMD reduction from baseline to the time of assessment2
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A ≥50% migraine responder was defined as a patient who achieved ≥50% reduction in MMDs from baseline, evaluated by comparing the baseline frequency of migraine days to an average value of migraine frequency measured across subsequent 4-week intervals.2

STUDY DESIGN
Proportion of patients with ≥50% MMD reduction from baseline to the time of assessment7
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A ≥50% migraine responder was defined as a patient who achieved ≥50% reduction in MMDs from baseline, evaluated by comparing the baseline frequency of migraine days to an average value of migraine frequency measured across subsequent 4-week intervals.2,7

STUDY DESIGN

Approximately one third of VYEPTI-treated patients with chronic migraine experienced at least 75% fewer migraine days within the first month versus baseline2

(PROMISE-2 secondary endpoint)
Proportion of patients with ≥75% MMD reduction from baseline to the time of assessment2
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26.7% of VYEPTI patients reported ≥75% reduction in MMDs from baseline at 12 weeks compared with 15% of placebo patients, p=0.0001.2 A ≥75% migraine responder was defined as a patient who achieved ≥75% reduction in MMDs from baseline, evaluated by comparing the baseline frequency of migraine days to an average value of migraine frequency measured across subsequent 4-week intervals.2

STUDY DESIGN

Patients with chronic migraine and MOH reduced their use of acute medication by more than 45% after their first VYEPTI infusion8

(Post hoc analysis of PROMISE-2)
Mean days per month of total acute medication use in patients with chronic migraine and MOH8
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These decreases in acute medication usage resulted in patients no longer meeting the monthly medication threshold for MOH, based on ICHD-3ß criteria8

Total acute headache medication days is the sum of triptan, ergotamine, opioid, simple analgesic, and combination analgesic days of use. If a patient used 2 classes of medication on the same day, they were counted twice.

STUDY DESIGN
Day 1 efficacy

VYEPTI starts working from day 1 after infusion2,3,5

(Post hoc analysis of PROMISE-1 and PROMISE-2)

VYEPTI starts working from day 1 after infusion2,3,5

(Post hoc analysis of PROMISE-1 and PROMISE-2)
Average daily percentage of patients with EM experiencing migraine5

Values for weeks 1 through 4 calculated as the average daily percentage of patients with a migraine during that week. Normalisation to average monthly days was achieved by multiplying the daily percent by 28 days (baseline period).5

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Day 1 reduction in proportion of patients experiencing migraine compared with baseline

VYEPTI 100 mg: 50.3%

Placebo: 27.1%

Values for weeks 1 through 4 calculated as the average daily percentage of patients with a migraine during that week. Normalisation to average monthly days was achieved by multiplying the daily percent by 28 days (baseline period).5

STUDY DESIGN
Average daily percentage of patients with CM experiencing migraine5

Values for weeks 1 through 4 calculated as the average daily percentage of patients with a migraine during that week. Normalisation to average monthly days was achieved by multiplying the daily percent by 28 days (baseline period).5

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Day 1 reduction in proportion of patients experiencing migraine compared with baseline

VYEPTI 100 mg: 52.3%

Placebo: 24.5%

Values for weeks 1 through 4 calculated as the average daily percentage of patients with a migraine during that week. Normalisation to average monthly days was achieved by multiplying the daily percent by 28 days (baseline period).5

STUDY DESIGN
Efficacy by 4-week interval

VYEPTI provides sustained migraine prevention in chronic migraine patients throughout each dosing period9

(PROMISE-2 secondary endpoint)
Reduction in mean MMD by 4-week interval, in patients with chronic migraine9
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Over 6 months, VYEPTI provides sustained migraine prevention with an average of 7.9 fewer migraine days each month relative to baseline9

Mean (SD) baseline MMDs were ~16.1 (4.6) across treatment groups.2,9

STUDY DESIGN
Administration

Intentionally designed for IV administration to deliver fast-acting anti-CGRP treatment10,11

VYEPTI is delivered via a 30-minute IV infusion, following dilution in a 100 mL bag of 0.9% Sodium Chloride for Injection1
  • Fast onset of preventive effects, reducing migraine frequency and acute medication use2,3,5,7,8
  • Sustained efficacy over 3 months could support patient adherence5,8
  • VYEPTI is generally well tolerated1,6
  • IV administration yields a predictable 100% bioavailability1
  • The recommended initiation and maintenance dose is 100 mg every 12 weeks1
  • The treating healthcare professional should observe or monitor patients during and after the infusion in accordance with normal clinical practice1

VYEPTI is generally well tolerated

  • Over 2,000 patients have been treated with VYEPTI in clinical studies, approximately half of which were exposed for 48 weeks (four doses)1
  • The most common side effects are nasopharyngitis, hypersensitivity reactions, infusion-related reaction and fatigue, which were mild to moderate in severity1,6
    1. Incidence of side effects generally decreased after subsequent doses, and hypersensitivity events resolved usually within 1 day1,6
  • Patients with a history of CV disease were excluded from clinical trials. No safety data are available in these patients1

Development of ADAs and NAbs does not appear to impact the efficacy and safety profiles of VYEPTI1,12

Summary of treatment-emergent adverse events from clinical trials6

Incidence of ≥2% of patients in any VYEPTI arm and 2 percentage points greater than placebo6

Adverse events should be reported.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Lundbeck Limited, Medical Information, on: 01908 638972 or Email: SafetyLuUnitedKingdom@lundbeck.com

Abbreviations:

ADA, anti-drug antibody; AHM, acute headache medication; BL, baseline; CGRP, calcitonin gene-related peptide; CV, cardiovascular; ECG, electrocardiogram; EM, episodic migraine; ICHD-3ß, International Classification of Headache Disorders 3rd edition (beta publication); IV, intravenous; MMD, monthly migraine day; MOH, medication overuse headache; NAb, neutralising antibody; SD, standard deviation; TEAE, treatment-emergent adverse event.

References:
  • Lundbeck. Vyepti. Summary of Product Characteristics GB and NI.
  • Lipton RB, et al. Neurology. 2020;94(13):e1365–77.
  • Ashina M, et al. Cephalalgia. 2020;40(3):241–54.
  • Martelletti P, et al. J Headache Pain. 2018;19(1):115.
  • Dodick DW, et al. Headache. 2020;60(10):2220–31.
  • Smith TR, et al. J Headache Pain. 2021;22(1):16.
  • Ashina M, et al. Lancet Neurol. 2022;21(7):597–607.
  • Marmura MJ, et al. Headache. 2021;61(9):1421–31.
  • Silberstein S, et al. J Headache Pain. 2020;21(1):120.
  • David L, et al. Bioengineered. 2021;12(2):11076-86.
  • Garcia-Martinez LF, et al. J Pharmacol Exp Ther. 2020;374(1):93-103.
  • Pederson S, et al. Front Immunol. 2021;12:765822.
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